Tailored CMC Regulatory Strategy for Pharmaceutical Companies
About RACatalyst
OUR MISSION
RegulatoryCatalyst specializes in helping emerging Pharma/Biotech Leaders facing a technical regulatory urgency to secure their submission packages, by providing blueprints and pathways, alleviating major risks threatening their approval timelines.
Our strategic Chemistry, Manufacturing, and Controls (CMC) solutions are designed to streamline approvals and reduce costs, giving you a competitive edge.
WE PROVIDE PHARMA/BIOTECH COMPANIES TECHNICAL (CMC] STRATEGIC AND EXECUTIVE CONSULTATIONS TO EFFECTIVELY REDUCE REGULATORY UNCERTAINTIES
You are biotech or pharma company, you strive for scientific and regulatory excellence, and you want to secure and accelerate your clinical development without burning capital — while staying fully in control of your timeline and quality.
Read this carefully.
I have spent more than 18 years in the global pharmaceutical industry, working at the intersection of technical and regulatory strategy within high-performance organizations such as Novartis, Lonza, and Sanofi.
From RA CMC Director to Founder of Jakob Partners Consulting Sarl, I have supported complex programs with the EMA and FDA, built regulatory submission strategies from first-in-human through post-approval, and conceptualized end-to-end regulatory processes.
After witnessing firsthand how much time and money biotech companies lose due to a lack of integrated regulatory strategy, I created RegCORE™ — a structured and modern framework that gives biotech leaders a clear, quantified, and validated regulatory roadmap, without relying on large, expensive consultancies or isolated freelancers.
I have helped startups and small pharma/biotech entities reduce regulatory uncertainty on both content and timelines, avoid major objections (including FDA Complete Response Letters), and secure their investor milestones.
Today, I help biotech founders and development leaders build robust regulatory plans, avoid CMC/clinical strategy missteps, and gain several months on their development timelines — a decisive competitive advantage at this stage.
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If today you face any of these challenges:
! Your team is under pressure to deliver a CMC dossier without regulatory certainty;
! Your external consultants work in silos and don’t give you a clear view of risks;
! You want to anticipate agency questions but don’t know where to start;
! You lack the time and resources to absorb the cost of re-work or re-submission;
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Then it’s time to adopt a structured approach:
✅ Get a validated regulatory roadmap (EMA + FDA) in 45 days — and run your project with full visibility.
✅ Reduce regulatory risk before submission, with a compliance analysis and a transparent readiness score.
✅ Free your team to focus on clinical and data priorities while the regulatory framework is secured.
✅ Save several months on your approval timeline and increase the perceived value of your development program with investors.
Still evaluating whether RegCORE™ is the right regulatory strategy for your program?
Download our Business Case
Download our transparent business case analysis based on a Phase I oncology program that avoided a 14-month timeline delay and €385K in rework costs by implementing a structured CMC gap closure plan. Inside this 60-page document, you'll find:
(1) a detailed regulatory readiness scorecard showing how gaps in analytical method validation and stability data create critical path delays,
(2) side-by-side timeline modeling comparing reactive vs. proactive regulatory strategy with probability-weighted scenarios,
(3) the five most expensive CMC documentation gaps that cause FDA clinical holds—with specific cost impact and resolution timelines for each,
(4) a self-assessment framework using the same scoring methodology from our Blueprint reports (0-100 scale across Pillar assessments), and
(5) ROI calculation templates showing break-even analysis for regulatory consulting investment vs. submission delay risk.
This business case uses the actual structure and risk quantification approach from RegCORE™ Blueprint Reports, giving you the same analytical rigor we provide to clients. No registration required, no sales follow-up, just transparent data to help you make an informed decision about your regulatory strategy, whether you engage with us or pursue another path.
SERVICES
RegCORE™ Blueprint
15,000€RegCORE™ is a 30–45 day deliverable that gives you a validated plan, risk score, and roadmap for submission — allowing you to prioritize studies and avoid agency “major questions”.Valid for 45 days- Targeted Strategic Regulatory Optimization
- CMC Gap Analysis and Risk Assesment Matrix
- Regulatory Pathway Blueprint
- Scientific Advice Prep CMC Package
From
TESTIMONIALS
Client Reviews
Our clients appreciate the expertise and dedication of RegulatoryCatalyst. Discover what they have to say about our transformative regulatory solutions.
Peter L.
Dear Jeremy,
It's been a pleasure working with you. PPL is very satisfied with the work conducted and the service provided during
the transfer of the RA responsibility to PPL
Clara F.
Mr. Jakob performs his tasks with especial commitment and takes obvious pleasure in his
work. He is reliable, responsible and particularly trustworthy at all times.
His fast way of working enables him to produce very good results.
Jakob B.
Jeremy is a very knowledgeable regulatory affairs professional. I appreciated his global technical CMC/Quality writing experience for small molecules and biologics DS and DP manufacturing documentation.
